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ENT Diagnostic Instruments
EUDAMEDClass I (EU MDR)
Ref 01-100-15Model 01-100-15 to 01-150-23
Identity
- Trade Name
- ENT Diagnostic Instruments EUDAMED
- Device Name
- ENT Diagnostic Instruments EUDAMED
- Model / Reference
- 01-100-15 to 01-150-23 EUDAMED01-100-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G16401100150X EUDAMED
- Basic UDI-DI
- ++G1640110015to011M2 EUDAMED
- EMDN Code
- L1699 DIAGNOSTIC INSTRUMENTS, REUSABLE- OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Latvia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ENT Diagnostic Instruments by Eltek Instruments Pvt Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G1640110015to011M2 | Class I | Active |
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Manufacturer
- Manufacturer
- Eltek Instruments Pvt Ltd
- EUDAMED SRN
- PK-MF-000024315
- Authorised Representative
- CS Active LV-AR-000011602
Sources (1)
- EUDAMED f33abca9-14ac-4fb5-af2e-4e74c57e551a 61 fields · synced Jun 18, 2026